Laser light with or without oxygen gel for mouth sores from radiotherapy
Compares laser light alone or with oxygen gel for radiotherapy mouth sores.
Plain-language title generated from the registry record
Registry title: Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Key facts
- Where
- Asyut, EgyptSee the site
- Phase
- Phase 1/2
Where in Egypt
- faculty of dentistry Assiut UniversityAsyut, EgyptNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assiut University
- Trial code
- NCT07865780
- Record updated
- 8 October 2026
- Original description
Oral mucositis is the inflammation and ulceration of the mucous membranes within the oral cavity, characterized by atrophy, edema, and erythema (1), and it occurs in nearly all patients with advanced head and neck cancer (HNC) receiving chemotherapy and radiotherapy [2,3]. It can seriously disrupt a person's life, affecting both quality of life and the course of treatment (2).Read full original descriptionShow less
Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Oral mucositis is the inflammation and ulceration of the mucous membranes within the oral cavity, characterized by atrophy, edema, and erythema (1), and it occurs in nearly all patients with advanced head and neck cancer (HNC) receiving chemotherapy and radiotherapy [2,3]. It can seriously disrupt a person's life, affecting both quality of life and the course of treatment (2).
Identifying the optimal management for oral mucositis remains a significant clinical challenge. Therapeutic modalities such as photobiomodulation (PBM) and benzydamine have shown beneficial effects in reducing mucosal injury and accelerating healing (3). In addition, maintaining proper oral hygiene and using adjunctive therapeutic agents can help minimize mucositis severity. Advanced interventions, including low-level laser therapy and optimized radiation delivery techniques like Intensity-Modulated Radiotherapy, may further reduce the incidence and severity of oral mucosal damage (4).
PBM can improve tissue regeneration, promote wound healing, and minimize pain and inflammation (5). Patients unable to take non-steroidal anti-inflammatory drugs can benefit from it in addition to enhancing tissue regeneration and post-surgery recovery (6).
Oxygen plays a fundamental role in wound healing, as it is required for cellular energy production, protein synthesis, cell proliferation, angiogenesis, and tissue repair. Oxygen tension varies by anatomical location, and wound sites often remain relatively hypoxic, which increases the risk of infection and ultimately delays or impairs tissue regeneration (7). Consequently, therapeutic strategies aimed at enhancing oxygen availability within the wound environment have been shown to promote more effective wound management and accelerated healing outcomes(8).
Inclusion: Adults (≥18 years old) undergoing chemotherapy and/or radiotherapy for head and neck cancers; Adequate general health status to tolerate the procedures (as determined by treating oncologist).
Exclusion: • Presence of severe oral mucositis (Grade IV) requiring enteral or parenteral nutrition; Known allergy or hypersensitivity to components of the topical oxygen gel or contraindications to laser therapy; Uncontrolled systemic diseases (e.g., diabetes mellitus, cardiovascular disease, or severe anemia); Pregnant or lactating women; Patients with photosensitivity disorders or those taking photosensitizing medications; Inability to maintain oral hygiene or attend follow-up visits.